MAUDE Adverse Event Report: TELEFLEX MEDICAL SCIS IRIS STR S/S 4.5"; SCISSORS,OPHTHALMIC

Catalog Number 144300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The radiologist used the scissors to remove some fibrin in a wound bed; the tip broke and dropped in the wound.He was able to retrieve the broken piece.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).This complaint is voided, because the product that was sent by the customer, concerning the reported defect is not a teleflex product.

Event Description

The radiologist used the scissors to remove some fibrin in a wound bed; the tip broke and dropped in the wound.He was able to retrieve the broken piece.The patient's condition was reported as fine.

• Brand Name: SCIS IRIS STR S/S 4.5"
• Type of Device: SCISSORS,OPHTHALMIC
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5827053
• MDR Text Key: 51497552
• Report Number: 3011137372-2016-00235
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 144300
• Device Lot Number: 05-1450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1